MAUDE Adverse Event Report: BIOMET 3I INTERNAL CONNECTION UNIVERSAL PLACEMENT DRIVER TIP - LONG; DENTAL INSTRUMENT-DRIVER

Catalog Number IIPDTUL

Device Problem Mechanical Problem (1384)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 02/01/2021

Event Type  malfunction  

Manufacturer Narrative

Upon reassessment of the reported event, it was determined that this event was filed under the incorrect catalog number, bopt6511.(see mfr number 0001038806-2021-00358).A retraction will be submitted for mfr number 0001038806-2021-00358.Catalog number bopt6511 is added as a concomitant device on this report.Zimmer biomet complaint number (b)(4).Weight unknown / not provided.Lot number unknown / not provided.Concomitant medical products: bopt6511, 3i t3¿ tapered implant 6/5 x 11.5mm, lot number: 2019052375.Pma/510(k) number not available.One 3i t3¿ tapered implant 6/5 x 11.5mm (bopt6511) was returned for investigation.However, one internal connection universal placement driver tip  long (iipdtul) was not returned.Visual evaluation of the as returned product identified damaged hex and platform being worn out.Implant external threads were somewhat damaged as well, likely from the retrieval process.Dhr review could not be performed for the driver tip (iipdtul) as the lot number was unknown.A year-long complaint history review was performed by items (iipdtul) using keyword category functional: damaged drive feature and no other complaints about nonconforming products were identified.May post market trending was reviewed and there were no actionable events or corrective actions for the reported event (damaged drive feature) or product (iipdtul).Therefore, based on the available information, device malfunction for driver tip could not be verified without the product return.A definitive root cause could not be identified.However, based on the investigation, risk file review and ifu, the most likely cause determined from the investigation are clinician failure to follow recommended protocol for implant placement and final seating or application of excessive torque.No further investigation or immediate capa / hhe/d escalation is required, as the complaint investigation did not confirm the product was nonconforming at the time of distribution, and no new failure mode, harm, or hazardous situation was identified through the investigation performed.

Event Description

It was reported that while placing an implant at tooth location #18 under torque @50 ncm w / hand piece, the surgeon describes loss of engagement.The surgeon stopped the procedure and found that the driver had stripped the hex of implant.The surgeon removed the implant with a removal kit and used another implant to complete the procedure.As a result of this event, no delays or injury to the patient was reported.

• Brand Name: INTERNAL CONNECTION UNIVERSAL PLACEMENT DRIVER TIP - LONG
• Type of Device: DENTAL INSTRUMENT-DRIVER
• Manufacturer (Section D): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• Manufacturer (Section G): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• Manufacturer Contact: susanne taylor ; 4555 riverside drive; palm beach gardens, FL 33410 ; 5617766700
• MDR Report Key: 12155046
• MDR Text Key: 261359738
• Report Number: 0001038806-2021-01243
• Device Sequence Number: 1
• Product Code: NDP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: IIPDTUL
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/30/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: DENTAL IMPLANT- .
• Patient Age: 47 YR